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Jill Wechsler is BioPharm International's Washington Editor, firstname.lastname@example.org.
Prominent scientists and political leaders at the International AIDS Conference in Washington, D.C., in late July were optimistic for the first time about bringing an end to the global AIDS pandemic. Medical advances over the past 30 years have led to development of nearly 30 effective antiretroviral (ARV) medicines, along with better methods for identifying infected individuals and for managing their care. New research indicates that ARVs can prevent HIV infection, which promises to reduce disease transmission and slow the spread of AIDS around the world-and also expand demand for AIDS therapies.
A “robust arsenal of antiviral drugs” and other interventions provide an opportunity for ending the HIV/AIDS pandemic, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, in a plenary address at this important biennial conference. “AIDS is on the run,” headlined The Economist, describing how the disease has shifted from a death sentence three decades ago to a manageable disease. Fauci and others raised the prospect of an AIDS vaccine. Talk of a “cure” was muted, but clearly in the minds of the 24,000 attendees of this international gathering.
Costs & coverage
Yet, nearly half of HIV-infected people in low- and middle-income countries are not receiving needed drug therapy, Fauci noted. The Centers for Disease Control and Prevention (CDC) reported that only one-third of Americans infected with AIDS get steady care, Caucasians doing better than African-Americans, and young people faring the worst.
The US and other nations and international organizations are spending some $17 billion a year on AIDS treatment programs in Africa and other regions. Another $22 billion, according to some estimates, is needed to provide appropriate care for all AIDS patients, an investment calculated to reduce the spread of infection sufficiently to bring the epidemic under control. Former President Bill Clinton put the cost of treating an AIDS patient in a poor nation at a record low of $200 a year, with less than half of that amount used to purchase drugs due to success in obtaining more low-cost generic therapies.
The big drop in outlays for medicines has been supported by FDA approval of generic versions of ARVs for use in poor nations through the President’s Emergency Plan for AIDS Relief (PEPFAR). FDA announced that it has tentatively approved more than 150 ARVs since 2003 to make patented drugs available to poor countries. Treatment costs may decline even more in the US as key ARVs lamivudine and efavirenz lose patent protection. Development of one-pill and once-per-day combination therapies promise to improve adherence with prescribed regimens, further curbing transmission and disease progression.
Further optimism arose from announcements on progress in developing effective antituberculosis drug cocktails, as well as evidence that an anticancer drug may undermine the AIDS virus in patients.
The big news at the conference was the prospect that antiretroviral drugs can prevent HIV infection in high-risk populations. Just before the meeting, FDA approved Gilead Science’s two-ARV combination treatment Truvada as a pre-exposure prophylaxis, or PrEP. Yet AIDS advocates raised concerns that over-reliance on drugs could do more harm than good. They and other experts urged continued promotion of condom use, voluntary male circumcision and prevention of mother-to-child transmission as more effective and affordable strategies for curbing the spread of infection.
Prices and priorities
The possibility that ARVs can prevent AIDS, moreover, raises the tricky ethical question of whether the US should spend $11,000 per patient to keep uninfected individuals healthy, when funds are lacking to provide life-saving treatment to millions of sick patients around the world.
The high cost of AIDS therapies in the US remains a sore issue in the AIDS community, which seeks seek strategies for negotiating cheaper rates. An analysis by Rand for the AIDS Healthcare Foundation examines a range of possibilities, including adoption of reference pricing, changing drug coverage for dual eligible beneficiaries in Medicare, authorizing federal government purchase all AIDS drugs, increasing price transparency to support open negotiations, and ending requirements that formularies cover all AIDS treatments to give plans and purchases added negotiating power.
Fauci and others urged donor nations and international organizations to recognize the value of spending more now to curb the spread of AIDS. Expanded treatment appears to reduce the rate of new infections, and conference officials released new guidelines calling for everyone infected with HIV to start ARV therapy immediately, instead of waiting until the disease progresses. This approach and other developments generated considerable optimism that a larger effort to control AIDS will pay very large dividends, and proposals for new taxes and other funding sources offer the prospect that needed funds will emerge.